Fleurstat BV Gel 45G

Overview

Fleurstat BVgel is a non-antibiotic bacterial vaginosis (BV) treatment that works to relieve BV symptoms and prevent recurrent BV.

Fleurstat BVgel is a non-antibiotic treatment for bacterial vaginosis (BV). It provides relief from BV symptoms, including unpleasant vaginal odour and discharge, helping to normalise vaginal pH and restore the normal vaginal flora balance.
Fleurstat BVgel also prevents recurrent BV by forming a physical barrier that blocks the attachment of BV-causing bacteria to the vaginal lining.

295465

Ingredients

Active ingredient: 1% w/w astodrimer sodium (VivaGel®)

Fleurstat BVgel contains astodrimer sodium (VivaGel ®) at a concentration of 10 mg/g (1% w /w) in a gel consisting of purified water, carbomer homopolymer type A, sodium hydroxide, glycerol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate (preservatives) and disodium edetate.

Fleurstat BVgel contains astodrimer sodium (VivaGel ®) at a concentration of 10 mg/g (1% w /w) in a gel consisting of purified water, carbomer homopolymer type A, sodium hydroxide, glycerol, propylene glycol, methyl hydroxybenzoate and propyl hydroxybenzoate (preservatives) and disodium edetate.

Instructions

Treatment: The recommended dose is one applicator full (equivalent to 5g) vaginally once daily, preferably at bedtime, for 7 days. It is important to complete all 7 doses, even if your symptoms go away.
Prevention: The recommended dose is one applicator full (equivalent to 5g) vaginally every second day, preferably at bedtime, for 16 weeks.
Directions for the multi-dose tube and disposable applicators
A single dose of Fleurstat BVgel (5g) is to be filled into the disposable applicator. Follow the steps below to prepare the applicator for use:
1. Remove cap from tube and puncture metal seal on tube with the pointed tip of cap.
2. Remove an applicator from the wrapper and screw end of applicator onto tube.
3. Slowly squeeze the tube from the bottom to fill the applicator with gel; the plunger will move as the applicator fills and will stop moving when the applicator contains the correct amount of gel.
4. Once filled, unscrew the applicator from the tube and replace the tube cap.
5. The filled applicator is now ready to be applied.
6. The applicator is inserted in the same way you would use a tampon applicator, so you may sit or stand depending on how you feel most comfortable.
7. Hold the applicator barrel between the thumb and middle finger and gently insert the applicator as far as comfortably possible into the vagina.
8. Holding the applicator in place, slowly push the plunger until it stops, dispersing the gel into the vagina.
9. Carefully remove the applicator, keeping the plunger depressed.
10. Discard used applicator into a suitable waste container.

Treatment: The recommended dose is one applicator full (equivalent to 5g) vaginally once daily, preferably at bedtime, for 7 days. It is important to complete all 7 doses, even if your symptoms go away.
Prevention: The recommended dose is one applicator full (equivalent to 5g) vaginally every second day, preferably at bedtime, for 16 weeks.
Directions for the multi-dose tube and disposable applicators
A single dose of Fleurstat BVgel (5g) is to be filled into the disposable applicator. Follow the steps below to prepare the applicator for use:
1. Remove cap from tube and puncture metal seal on tube with the pointed tip of cap.
2. Remove an applicator from the wrapper and screw end of applicator onto tube.
3. Slowly squeeze the tube from the bottom to fill the applicator with gel; the plunger will move as the applicator fills and will stop moving when the applicator contains the correct amount of gel.
4. Once filled, unscrew the applicator from the tube and replace the tube cap.
5. The filled applicator is now ready to be applied.
6. The applicator is inserted in the same way you would use a tampon applicator, so you may sit or stand depending on how you feel most comfortable.
7. Hold the applicator barrel between the thumb and middle finger and gently insert the applicator as far as comfortably possible into the vagina.
8. Holding the applicator in place, slowly push the plunger until it stops, dispersing the gel into the vagina.
9. Carefully remove the applicator, keeping the plunger depressed.
10. Discard used applicator into a suitable waste container.

For treatment of BV, the recommended dose is one applicator full (equivalent to 5g) vaginally once daily, preferably at bed time for 7 days.
For prevention of recurrent BV, the recommended dose is one applicator (equivalent to 5g) vaginally once every second day, preferably at bed time.

Storage

Store Fleurstat BVgel below 30ﹾC. Do not refrigerate or freeze.

Safety

• For vaginal use only.
• Keep out of reach of children.
• Do not use the product if the applicators are unwrapped or the wrapper is torn.
• Do not use the product if the container/tube is broken or dirty or appears to be tampered with.
• Only use the recommended dose as specified in these instructions.
• Do not use Fleurstat BVgel if you have a history of sensitivity to any ingredient of the formulation.
• See a doctor if you are pregnant or diabetic. See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed.
• Do not use for more than 7 days unless a doctor has told you to.
• See a doctor before using Fleurstat BVgel for the prevention of recurrent BV.
• Use of Fleurstat BVgel beyond 16 weeks is not recommended without medical supervision.
• When using the product for the treatment of BV consult a doctor if no better after 7 days, or if symptoms recur within two weeks of completing the course.
• See your healthcare provider if you consider that you may be at risk of a Sexually Transmitted Infection (STI).
• Laboratory-based studies of Fleurstat BVgel have not demonstrated a risk to the foetus, but there are no adequate and well-controlled clinical studies in pregnant or breastfeeding women and the effects on an unborn child have not been fully investigated.

• For vaginal use only.
• Keep out of reach of children.
• Do not use the product if the applicators are unwrapped or the wrapper is torn.
• Do not use the product if the container/tube is broken or dirty or appears to be tampered with.
• Only use the recommended dose as specified in these instructions.
• Do not use Fleurstat BVgel if you have a history of sensitivity to any ingredient of the formulation.
• See a doctor if you are pregnant or diabetic. See a doctor if you plan to become pregnant, or are breastfeeding or plan to breastfeed.
• Do not use for more than 7 days unless a doctor has told you to.
• See a doctor before using Fleurstat BVgel for the prevention of recurrent BV.
• Use of Fleurstat BVgel beyond 16 weeks is not recommended without medical supervision.
• When using the product for the treatment of BV consult a doctor if no better after 7 days, or if symptoms recur within two weeks of completing the course.
• See your healthcare provider if you consider that you may be at risk of a Sexually Transmitted Infection (STI).
• Laboratory-based studies of Fleurstat BVgel have not demonstrated a risk to the foetus, but there are no adequate and well-controlled clinical studies in pregnant or breastfeeding women and the effects on an unborn child have not been fully investigated.

ASK YOUR PHARMACIST ABOUT THIS PRODUCT.

Do not use for more than 7 days unless a doctor has told you to. See your doctor if symptoms persist after 7 days or recur within 2 weeks of completing a course, or if you consider you may be at risk of a Sexually Transmitted Infection (STI). See a doctor if you are diabetic or pregnant/breastfeeding (or plan to be).

You can use Fleurstat BVgel when you don’t have symptoms to help prevent recurrent BV and its symptoms. Recurrent BV is typically 3 or more episodes in a 12-month period. See a doctor before using Fleurstat BVgel for the prevention of recurrent BV. Use of Fleurstat BVgel beyond 16 weeks is not recommended without medical supervision.

Country of Origin

Belgium